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Omega-3 Fatty Acid in Preventing Breast Cancer in Premenopausal Women Considering Future Pregnancy

Trial Status: Active

This pilot trial studies how well omega-3 fatty acid works in preventing breast cancer in premenopausal women who consider pregnancy in the future. Moderate dose omega-3 fatty acid may help prevent breast cancer from forming in patients with high risk for breast cancer.

Inclusion Criteria

  • Women must be pre-menopausal as defined as having intact ovaries with regular menses or if not menstruating, have a premenopausal status confirmed by serum follicle-stimulating hormone (FSH) and estradiol
  • Women must be considered at high risk for breast cancer based on family history (first or second degree relative diagnosed with breast cancer under the age of 60), prior precancerous biopsy or a 5-year Gail model risk estimate of >= 1.7% or 10-year Tyrer-Cuzick risk of 2 x population risk as listed in the model
  • Women must indicate that they are still considering future pregnancy and childbearing
  • Women must be one year from pregnancy and breast-feeding
  • Women must be willing to take supplemental omega-3 fatty acids provided by the study

Exclusion Criteria

  • Women actively undergoing in-vitro fertilization or fertility treatments are excluded
  • Women currently pregnant or breast-feeding at time of study consent
  • Women with an active malignancy
  • Women on anticoagulation
  • Women with bilateral breast implants or tram flap reconstruction
  • Women who have had radiation to both breasts
  • Women with current mammographic or clinical breast exam mass which is suspicious for breast cancer and malignancy has not been ruled out

Kansas

Fairway
University of Kansas Clinical Research Center
Status: ACTIVE
Contact: Lauren Nye
Phone: 913-588-7750
Email: lnye@kumc.edu
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Contact: Lauren Nye
Phone: 913-588-7750
Email: lnye@kumc.edu

PRIMARY OBJECTIVES:

I. Feasibility of the study in pre-menopausal women at high risk for breast cancer and considering future pregnancy.

II. Documentation of compliance of moderate dose omega-3 fatty acids in pre-menopausal women prior to and during pregnancy.

III. Identification of novel biomarkers modulated by moderate dose omega-3 fatty acids in pre-menopausal women prior to and during pregnancy.

OUTLINE:

Participants receive omega-3 fatty acid orally (PO) daily for 6 months.

After completion of study, participants are followed up periodically.

Trial Phase Phase NA

Trial Type Prevention

Lead Organization
University of Kansas Cancer Center

Principal Investigator
Lauren Nye

  • Primary ID Moderate Dose Omega 3
  • Secondary IDs NCI-2018-00311
  • Clinicaltrials.gov ID NCT03383835